Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 April 2013 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2013-05-31
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013154EN.01000801.xml










31.5.2013   


EN


Official Journal of the European Union


C 154/8





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 April 2013

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
 (1)
or Article 38 of Directive 2001/82/EC
 (2)
)

2013/C 154/02
—   Issuing, maintenance or modification of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




10.4.2013


Kantos Master and associated names


See Annex


See Annex


11.4.2013






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State in EU/EEA


Marketing authorisaton holder


Product name


Strength


Pharmaceutical form


Route of administration




Austria







Chiesi Pharmaceuticals GmBH Gonzagagasse 16/16 Vienna




A-1010




Austria






Formodual 100/6 Mikrogramm/Sprühstoß, Druckgasinhalation, Lösung


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Belgium







Chiesi Farmaceutici S.p.A.




via Palermo 26/A,




Parma 43122




Italy






Inuvair


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Bulgaria







Chiesi Pharmaceuticals GmBH Gonzagagasse 16/16 Vienna




A-1010




Austria






Foster


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Cyprus







Chiesi Farmaceutici S.p.A.




via Palermo 26/A,




Parma 43122




Italy






Foster


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Denmark







Chiesi Farmaceutici S.p.A.




via Palermo 26/A,




Parma 43122




Italy






Innovair


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Estonia







Chiesi Pharmaceuticals GmBH Gonzagagasse 16/16 Vienna




A-1010




Austria






Foster


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Finland







Chiesi Farmaceutici S.p.A.




via Palermo 26/A,




Parma 43122




Italy






Innovair


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




France







CHIESI S.A.




11 avenue Dubonnet




COURBEVOIE




92400




France






Formodual


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Germany







Chiesi Farmaceutici S.p.A.




via Palermo 26/A,




Parma 43122




Italy






Kantos Master


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Greece







UCB A.E. 63,




Ag. Dimitriou Str.,




GR 174 56 Alimos,




Greece






Inuvair


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Hungary







Chiesi Pharmaceuticals GmBH Gonzagagasse 16/16 Vienna




A-1010




Austria






Formodual


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Italy







Chiesi Farmaceutici S.p.A.




via Palermo 26/A,




Parma 43122




Italy






Inuver


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Latvia







Chiesi Pharmaceuticals GmBH Gonzagagasse 16/16 Vienna




A-1010




Austria






Foster


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Lithuania







Chiesi Pharmaceuticals GmBH Gonzagagasse 16/16 Vienna




A-1010




Austria






Foster


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Luxembourg







Chiesi Farmaceutici S.p.A.




via Palermo 26/A,




Parma 43122




Italy






Inuvair


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Norway







Chiesi Farmaceutici S.p.A.




via Palermo 26/A,




Parma 43122




Italy






Inuxair


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Poland







Chiesi Pharmaceuticals GmBH Gonzagagasse 16/6 Vienna




A-1010




Austria






Formodual


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Romania







Chiesi Pharmaceuticals GmBH Gonzagagasse 16/16 Vienna




A-1010




Austria






Foster


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Slovenia







Chiesi Pharmaceuticals GmBH Gonzagagasse 16/16 Vienna




A-1010




Austria






Formodual


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Spain







Chiesi España, S.A. Plaça d’Europa,




41-43, Planta 10,




08908 L’Hospitalet de Llobregat,




Barcelona,




España






Formodual


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




Sweden







Chiesi Farmaceutici S.p.A.




via Palermo 26/A,




Parma 43122




Italy






Innovair


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




The Netherlands







Chiesi Farmaceutici S.p.A.




via Palermo 26/A,




Parma 43122




Italy






Foster


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use




United Kingdom







Chiesi Limited,




Cheadle Royal Business Park,




Highfield,




Cheadle,




Cheshire SK8 3GY,




UK






Formodual


100/6 micrograms per actuation


pressurised inhalation solution


inhalation use